Accommodating intraocular lens having dual shape memory optical elements

ABSTRACT

An accommodating intraocular lens (AIOL) for implantation in a human eye includes a housing including an anterior member with a leading surface, a posterior member with a trailing surface, a leading shape memory optical element adjacent the anterior member and resiliently elastically deformable between a non-compressed shape in a non-compressed state of the AIOL and a compressed shape in a compressed state of the AIOL, and a trailing shape memory optical element adjacent the posterior member and elastically deformable between a non-compressed shape in the AIOL&#39;s non-compressed state and a compressed shape in the AIOL&#39;s compressed state for selectively bulging into the leading shape memory optical element on application of a compression force the said longitudinal axis against the trailing surface from a posterior direction for modifying the shape of the leading shape memory optical element with respect to its non-compressed shape in the AIOL&#39;s the non-compressed state.

This application is a Continuation Application of U.S. patentapplication Ser. No. 13/604,172 filed Sep. 5, 2012, to be issued as U.S.Pat. No. 8,834,565 on Sep. 16, 2014, which is a Continuation Applicationof U.S. patent application Ser. No. 11/910,133 filed May 21, 2008 (nowabandoned), which was a national stage application for PCT/IL2006/000406filed Mar. 30, 2006, claiming priority to U.S. 60/666,180 filed Mar. 30,2005, U.S. 60/672,081 filed Apr. 18, 2005, and U.S. 60/724,896 filedOct. 11, 2005, all of which are incorporated herein by reference intheir entirety.

FIELD OF THE INVENTION

The invention pertains to accommodating intraocular lens assemblies.

BACKGROUND OF THE INVENTION

Commonly owned PCT International Application No. PCT/IL02/00693 entitledAccommodating Lens Assembly and published on 27 Feb. 2003 under PCTInternational Publication No. WO 03/015669 illustrates and describesaccommodating intraocular lens (hereinafter AIOL) assemblies, thecontents of which are incorporated herein by reference. The AIOLassemblies each include a haptics system adapted to be securely fixed ina human eye's annular ciliary sulcus at at least two spaced apartstationary anchor points so that it may act as a reference plane for anAIOL of continuously variable Diopter strength affected by a human eye'scapsular diaphragm under control of its sphincter-like ciliary body andacting thereagainst from a posterior direction. The haptics systemsinclude a rigid planar haptics plate with a telescoping haptics memberfor sliding extension. The haptics plate and the haptics member arepreferably self-anchoring as illustrated and described in commonly ownedPCT International Application No. PCT/IL02/00128 entitled IntraocularLens and published on 29 Aug. 2002 under PCT International PublicationNo. WO 02/065951, the contents of which are incorporated herein byreference.

Commonly owned PCT International Application No. PCT/IL2005/000456entitled Accommodating Intraocular Lens Assemblies and AccommodationMeasurement Implant and published on 10 Nov. 2005 under PCTInternational Publication No. WO 2005/104994 illustrates and describesAIOL assemblies enabling post implantation in situ manual selectivedisplacement of an AIOL along a human eye's visual axis relative to atleast two spaced apart stationary anchor points to a desired position toensure that an AIOL assumes a non-compressed state in a human eye'sconstricted ciliary body state. Such in situ manual selectivedisplacement can be effected post implantation to correct for capsularcontraction which is a natural reaction which typically develops over afew months following extraction of the contents of a human eye's naturalcrystalline lens, and also a subject's changing eyesight overtime withminimal clinical intervention. Such in situ manual selectivedisplacement can be achieved as follows: First, a discrete hapticssystem for retaining a discrete AIOL which is manually displaceablerelative thereto. And second, a haptics system with at least two hapticshaving radiation sensitive regions capable of undergoing plasticdeformation for in situ manual displacement of an integrally formedAIOL.

Commonly owned PCT International Application No. PCT/IL2005/001069entitled Accommodating Intraocular Lens (AIOL), and AIOL AssembliesIncluding Same illustrates and describes an AIOL including a biasingmechanism for elastically deforming an elastically deformable shapememory disk-like optical element for affording the AIOL a naturalpositive Diopter strength for near vision. The AIOL is intended to beimplanted in a human eye such that relaxation of its ciliary body causesits capsular diaphragm to apply an external force for overcoming thebiasing mechanism to reduce the AIOL's natural positive Diopter strengthfor distance vision.

Other AIOLs are illustrated and described in U.S. Pat. No. 4,254,509 toTennant, U.S. Pat. No. 4,409,691 to Levy, U.S. Pat. No. 4,888,012 toHorn et al., U.S. Pat. No. 4,892,543 to Turley, U.S. Pat. No. 4,932,966to Christie et al., U.S. Pat. No. 5,476,514 to Cumming, U.S. Pat. No.5,489,302 to Skottun, U.S. Pat. No. 5,496,366 to Cumming, U.S. Pat. No.5,522,891 to Klaas, U.S. Pat. No. 5,674,282 to Cumming, U.S. Pat. No.6,117,171 to Skottun, U.S. Pat. No. 6,197,059 to Cumming, U.S. Pat. No.6,299,641 to Woods, U.S. Pat. No. 6,342,073 to Cumming et al., U.S. Pat.No. 6,387,126 to Cumming, U.S. Pat. No. 6,406,494 to Laguette et al.,U.S. Pat. No. 6,423,094 to Sarfarazi, U.S. Pat. No. 6,443,985 to Woods,U.S. Pat. No. 6,464,725 to Skotton, U.S. Pat. No. 6,494,911 to Cumming,U.S. Pat. No. 6,503,276 to Lang et al., U.S. Pat. No. 6,638,306 toCumming, U.S. Pat. No. 6,645,245 to Preussner, U.S. Patent ApplicationPublication No. US 2004/0169816 to Esch, and EP 1 321 112.

SUMMARY OF THE INVENTION

One aspect of the present invention is directed towards accommodatingintraocular (AIOL) assemblies each including at least one shape memoryoptical element resiliently elastically deformable between anon-compressed shape with a first Diopter strength and a compressedshape with a second Diopter strength different than its first Diopterstrength such that an AIOL has a continuously variable Diopter strengthbetween a minimum Diopter strength for distance vision purposes and amaximum Diopter strength for near vision purposes. The AIOL assembliesare intended for in situ manual selective displacement of an AIOL alonga human eye's visual axis relative to stationary anchor points afterimplantation for enabling accurate AIOL deployment to take fulladvantage of the reciprocal movement of a human eye's capsular diaphragmbetween its constricted ciliary body position and its relaxed ciliarybody position. Axial displacement may be over a continuous range in asimilar manner to aforesaid WO 2005/104994 or alternatively at discreteaxial stopping positions typically from about 100 μm to about 300 μmapart. Stepwise axial displacement is preferably enabled by a so-called“push and twist” bayonet arrangement similar to a conventional lightbulb fitting having a single stopping position. The AIOL assemblies eachinclude a haptics system also suitable for self-anchoring implantationof a fixed Diopter strength IOL in a human eye as opposed to an AIOLhaving a variable Diopter strength.

Another aspect of the present invention is directed towards AIOLs whichlend themselves to be at least partially folded under reasonable forcesas can be applied using conventional ophthalmic surgical tools, forexample, tweezers, for facilitating insertion into a human eye through arelatively small incision. The AIOLs can be provided as discretecomponents for use with discrete haptics systems for enabling aforesaidin situ axial displacement. The discrete ATMs are provided withtypically two or more manipulation apertures accessible from an anteriorside for receiving the tip of a handheld manipulation tool for enablingin situ manipulation. The manipulation apertures may be in the form ofperipheral disposed manipulation rings, blind manipulation notches, andthe like. Alternatively, the AIOLs can be integrally formed with ahaptics system including at least two elongated haptics having radiationsensitive regions capable of undergoing plastic deformation for enablingaforesaid in situ axial displacement.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it can be carriedout in practice, preferred embodiments will now be described, by way ofnon-limiting examples only, with reference to the accompanying drawingsin which similar parts are likewise numbered, and in which:

FIG. 1 is a cross section view of an anterior part of a human eye in itsnatural near vision condition in an axial plane of the human body;

FIG. 2 is a cross section view of an anterior part of a human eye in itsnatural distance vision condition in an axial plane of the human body;

FIG. 3 is a pictorial view of a disassembled “push and twist” AIOLassembly including a discrete haptics system and a discrete AIOL with aflattened spherical shaped housing a shape memory optical element;

FIG. 4 is a close-up front view of a bifurcated attachment plate of FIG.3's haptics system;

FIG. 5 is a pictorial view of a stepped track of FIG. 3's hapticssystem;

FIG. 6 is a pictorial view of a FIG. 3's AWL being folded by tweezersfor insertion into a human eye through a small incision;

FIG. 7 is a pictorial view of a unitary AIOL assembly including ahaptics system integrally formed with FIG. 3's AIOL;

FIG. 8 is a longitudinal cross section view of the FIG. 3's AIOL in itsnon-compressed state along line B-B in FIG. 3;

FIG. 9 is a longitudinal cross section of FIG. 3's AIOL in itscompressed state along line B-B in FIG. 3;

FIG. 10 is a side view of FIG. 3's AIOL assembly prior to assembly;

FIG. 11 is a side view of FIG. 3's AIOL assembly at its most posterioraxial stopping position;

FIG. 12 is a side view of FIG. 3's AIOL assembly at an intermediateaxial stopping position;

FIG. 13 is a side view of FIG. 3's AIOL assembly at its most anterioraxial stopping position;

FIG. 14 is a cross section view of an anterior view of a human eye in anaxial plane of the human body implanted with FIG. 3's AIOL assembly inan initial position along the human eye's visual axis;

FIG. 15 is a cross section view of an anterior view of a human eye in anaxial plane of the human body implanted with FIG. 3's AIOL assembly at asubsequent position along the human eye's visual axis to compensate forcapsular contraction;

FIG. 16 is a pictorial view of a disassembled “push and twist” AIOLassembly including a discrete haptics system and a discrete dualbellows-like AIOL;

FIG. 17 is a pictorial view of a unitary AIOL assembly including ahaptics system integrally formed with FIG. 16's dual bellows-like AIOL;

FIG. 18 is a longitudinal cross section view of FIG. 16's dualbellows-like AIOL in its non-compressed state;

FIG. 19 is a longitudinal cross section of FIG. 16's dual bellows-likeAIOL in its compressed state;

FIG. 20 is a cross section view of an anterior view of a human eye inits contracted ciliary body state in an axial plane of the human bodyimplanted with FIG. 16's AIOL assembly;

FIG. 21 is a cross section view of an anterior view of a human eye inits relaxed ciliary body state in an axial plane of the human bodyimplanted with FIG. 16's AIOL assembly;

FIG. 22 is an exploded view of a still yet another discrete AIOL for usein a haptics system adapted to be securely fixed in a human eye'sannular ciliary sulcus;

FIG. 23 is a longitudinal cross section view of FIG. 22's AIOL in itsnon-compressed state;

FIG. 24 is a longitudinal cross section view of FIG. 22's AIOL in itscompressed state;

FIG. 25 is a side view of a still yet another discrete AIOL in itsnon-compressed state for use in a haptics system adapted to be securelyfixed in a human eye's annular ciliary sulcus;

FIG. 26 is a side view of FIG. 25's AIOL in its compressed state;

FIG. 27 is a cross section view of FIG. 25's AIOL in its non-compressedstate;

FIG. 28 is a cross section view of FIG. 25's AIOL in its compressedstate;

FIG. 29 is longitudinal cross section view of a still yet anotherdiscrete AIOL in its non-compressed state for use in a haptics systemadapted to be securely fixed in a human eye's annular ciliary sulcus;

FIG. 30 is a longitudinal cross section of FIG. 29's AIOL in itscompressed state;

FIG. 31 is a longitudinal cross section of still yet another discreteAIOL in its non-compressed state for use in a haptics system adapted tobe securely fixed in a human eye's annular ciliary sulcus;

FIG. 32 is a longitudinal cross section of a still yet another discreteAIOL in its non-compressed state for use in a haptics system adapted tobe securely fixed in a human eye's annular ciliary sulcus;

FIG. 33 is a pictorial view of a disassembled “push and twist” AIOLassembly in accordance with another “push and twist” bayonetarrangement;

FIG. 34 is a pictorial view of a disassembled “push and twist” AIOLassembly in accordance with yet another “push and twist” bayonetarrangement; and

FIG. 35 is a pictorial view of a disassembled AIOL assembly with a screwthread arrangement for enabling in situ manual selective axialdisplacement of an AIOL along a human eye's visual axis.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE PRESENT INVENTION

FIGS. 1 and 2 are cross section views of an anterior part of a human eye10 having a visual axis VA in its natural near and distance visionconditions, respectively, in an axial plane of the human body. The humaneye 10 has a cornea 11 peripherally connected to a spherical exteriorbody made of tough connective tissue known as the sclera 12 at anannular sclero-corneal juncture 13. An iris 14 inwardly extends into thehuman eye 10 from its root 16 at the sclero-corneal juncture 13 todivide the human eye's anterior part into an anterior chamber 17 and aposterior chamber 18. A sphincter-like peripheral structure known as theciliary body 19 includes ciliary processes housing ciliary muscles 21fired by parasympathetic nerves. The ciliary muscles 21 are connected tozonular fibers 22 which in turn are peripherally connected to theequatorial edge of a membrane known as the capsular bag 23 with ananterior capsule 24 and a posterior capsule 26 enrobing a naturalcrystalline lens 27. The iris's root 16 and the ciliary body 19 delimita portion of the interior surface of the sclera 12 at the sclero-cornealjuncture 13 known as the ciliary sulcus 28. Remnants of the anteriorcapsule 24 which may remain after extraction of the natural crystallinelens 27 and the intact posterior capsule 26 are referred to hereinafteras the capsular diaphragm 29. Contraction of the ciliary body 19 allowsthe lens 27 to thicken to its natural thickness T1 along the visual axisVA for greater positive optical power for near vision (see FIG. 1).Relaxation of the ciliary body 19 tensions the zonular fibers 22 whichdraws the capsular bag 23 radially outward as shown by arrows A forcompressing the lens 27 to shorten its thickness along the visual axisVA to T2<T1 for lower positive optical power for distance vision (seeFIG. 2).

FIG. 3 shows a “push and twist” AIOL assembly 31 for self-anchoring in ahuman eye's ciliary sulcus 28 for preferably enabling spectacle freevision over the nominal range of human vision. The AIOL assembly 31includes a discrete haptics system 32 for selectively retaining adiscrete AIOL 33, and a “push and twist” bayonet arrangement 34 foreffecting stepwise axial displacement of the AIOL 33 relative to thehaptics system 32 and therefore along a human eye's visual axis. Ahandheld manipulation tool 36 with an elongated shaft 37 and an inclinedend piece 38 with a tip 38A is employed for assembling the AIOL assembly31 in situ and for manipulating the AIOL 33 for stepwise axialdisplacement relative to the haptics system 32.

The haptics system 32 is made from suitable rigid bio-compatibletransparent polymer material such as PMMA, and the like. The hapticssystem 32 has a longitudinal axis 39 intended to be co-directional witha human eye's visual axis. The haptics system 32 includes a tubular mainbody 41 with a diameter D1 in the region of 4 mm-5 mm corresponding to ahuman eye's pupil, and an axial length L1 of 1 mm±0.5 mm along thelongitudinal axis 39 (see FIG. 10). The haptics system 32 has a pair ofdiametrically opposite elongated C-shaped haptics 42 extending from itsmain body 41 in opposite directions in a plane perpendicular to itslongitudinal axis 39. The haptics 42 have a thin profile in the planeperpendicular to the longitudinal axis 39 such that they aresufficiently flexible under reasonable forces as can be applied usingconventional ophthalmic surgical tools for encircling around the mainbody 41 shown by arrow C for facilitating insertion of the hapticssystem 32 into a human eye through a relatively small incision. FIG. 3shows a haptics 42 in dashed lines for showing its encircling around themain body 41. The haptics 42 have a wide profile along the longitudinalaxis 39 such that they are rigid against a compression force therealong.The haptics' wide profile preferably tapers from its proximal end 42Aadjacent the main body 41 to its distal end 42B remote therefrom andterminating at a bifurcated attachment plate 43.

FIG. 4 shows an attachment plate 43 has a near square shape in a frontview in the plane perpendicular to the longitudinal axis 39 and isformed with a pair of spaced apart pointed puncturing members 44 ofsufficient strength for forced penetration into the tough connectivetissue of a human eye's sclera 12. The attachment plate 43 has anisosceles shaped cutout 46 pointing towards its haptics 42 to leave acentral narrow juncture 47 for determining the maximal penetration ofthe attachment plate 43 into a human eye's sclera 12 on its abutmentthereagainst. The puncturing members 44 have tips 44A with a minimum tipseparation TS of at least 1 mm and preferably between about 2 mm and 3mm in the plane perpendicular to the longitudinal axis 39. Thepuncturing members 44 have a minimum tip height TH of at least 0.5 mm asmeasured between the tips 44A and the juncture 47 such that they canpenetrate slightly more than half of a sclera's thickness of about 1 mm.The tip height TH is preferably between about 0.8 mm and 1.3 mm. Theattachment plates 43 are formed with a manipulation aperture 48 in thecentral portion between the cutout 46 and the haptics 42 for selectivelyreceiving the handheld manipulation tool's tip 38A for in situmanipulation purposes. The manipulation aperture 48 is preferablyconstituted by an about 0.4 mm diameter throughgoing bore.

The main body 41 has an internal surface 51 formed with two or moreequidistant stepped tracks 52 only one of which is visible in FIG. 3.FIG. 5 shows a stepped track 52 has three axial directed channels 53A,53B and 53C enabling axial displacement of the AIOL 33 relative to thehaptics system 32 and three peripheral grooves 54A, 54B and 54C enablingrotational displacement of the AIOL 33 relative to the haptics system 32and precluding inadvertent slipping of the AIOL 33 in an axial directionrelative to a human eye's visual axis. The axial directed channels haveperipheral widths W. The peripheral grooves 54A correspond to a mostposterior stopping position, the peripheral grooves 54B correspond to anintermediate position, and the peripheral grooves 54C correspond to amost anterior position of an AIOL along a human eye's visual axis,respectively.

FIGS. 3, 8 and 9 show the AIOL 33 has a longitudinal axis 56 intended tobe co-directional with a human eye's visual axis, and a hollow flattenedspherical shaped housing 57, an annular anterior member 58 with aleading surface 58A, and a posterior member 59 having a trailing surface59A. The leading surface 58A has an internal rim 61 defining an anteriorfacing aperture 62 having a diameter slightly smaller than that of themain body 41. The housing 57 defines a cavity 63 housing a shape memoryoptical element 64 with a leading surface 66 with a central portion 66Aexposed through the aperture 62. The posterior member 59 can be formedwithout any optical power or preferably as a plano-convex optical memberwith positive Diopter strength as shown. The housing 57 has a diameterD2 of at least 6 mm for an adult sized AIOL 33, and preferably of about7 mm±1 mm so as to bear against a major portion of a human eye'scapsular diaphragm 29 (see FIG. 10).

The AIOL 33 includes a rigid tubular casing 67 having an axial length L2and a leading end 67A for facing in an anterior direction in a humaneye, and a trailing end 67B for facing in a posterior direction in ahuman eye (see FIG. 10). The trailing end 67B is formed with a groove 68for receiving the internal rim 61 whereupon the casing 67 canreciprocate relative thereto for selectively compressing the opticalelement 64. The casing 67 has a peripheral cylindrical surface 69 withlugs 71 for traveling along the stepped tracks 52. The lugs 71 haveperipheral lengths L3 where W=L3+Δ. The housing 57 is formed withmanipulation rings 72 on its peripheral rim 57A and/or blindmanipulation notches 73 on its leading surface 58A for selectivelyreceiving the handheld manipulation tool's tip 38A for enabling in situmanipulation of the AIOL 33 from an anterior direction on implantationof the AIOL 33 in a human eye.

The housing 57, the optical element 64 and the casing 67 are preferablyformed from suitable biocompatible transparent polymer material ofdifferent consistencies which can be elastically deformed underreasonable forces as can be applied using conventional ophthalmicsurgical tools, for example, tweezers 74, and the like, for facilitatinginsertion of the AIOL 33 into a human eye through a relatively smallincision (see FIG. 6). The casing 67 is typically formed from arelatively rigid polymer material, for example, PMMA, whilst the housing57 is formed from less rigid silicone or acrylic based polymer material,and the optical element 64 is formed from still softer silicone gel, orsofter acrylic based polymer material. For example, the housing 57 canbe formed from MED6400 polymer material and the optical element 64 canbe formed from MED3-6300 polymer material both polymer materials beingcommercially available from NuSil Silicon Technology, Inc., California,USA (www.nusil.com).

FIG. 7 shows a unitary AIOL assembly 80 having a longitudinal axis 81intended to be co-directional with a human eye's visual axis, and ahaptics system 82 integrally formed with the AIOL 33 which therebyeffectively acts as the haptics system's main body. The haptics system82 includes a pair of diametrically opposite elongated C-shaped haptics83 extending from its AIOL 33 in opposite directions in a planeperpendicular to the longitudinal axis 81 in a similar manner to thehaptics system 32. In this case, the haptics 83 have regions 84impregnated with radiation sensitive bio-compatible materials such as IRsensitive indocyanine green (ICG), and the like, such that they arecapable of being plastically deformed on heating to a so-called glasstransmission temperature to enable post implantation in situ axialdisplacement as illustrated and described in aforesaid WO2005/104994.

FIG. 8 shows the non-compressed shape of the optical element 64 has acontinuous slightly curvilinear leading surface 66 including its exposedcentral portion 66A in the AIOL's non-compressed state. FIG. 9 shows thecompressed shape of the optical element 64 bulging anteriorly into thecasing 67 on applying a compression force F along its longitudinal axis39 for compressing the AIOL 33 into its compressed state. The bulgingshape is dependent on the compression force and bulges more in itscompressed shape than its non-compressed shape whereby the AIOL 33 has acontinuously variable Diopter strength from a minimum Diopter strengthsuitable for distance vision and a maximum Diopter strength suitable fornear vision. The optical element 64 typically has a refractive indexsimilar to that of the natural crystalline lens 27 or greater whereuponits non-compressed state is suitable for distance vision and itscompressed state is suitable for near vision. In the case that theoptical element 64 has a refractive index less than the human eye'saqueous humor, the optical element 64 acts as a concave lens such thatits non-compressed state is suitable for near vision and its compressedstate is suitable for distance vision.

FIGS. 10-13 show the use of the “push and twist” bayonet arrangement 34for in situ adjustment of the AIOL 33 along a human eye's visual axis.The AIOL 33 is deployed posterior to the haptics system 32 and isrotated to align its lugs 71 with the channels 53A. The AIOL 33 isdisplaced in an anterior direction to insert its lugs 71 into thechannels 53A and is rotated in a clockwise direction on facing the AIOL33 from a posterior direction to midway along the grooves 54A forassuming its most posterior position (see FIG. 11). Positioning the AIOL33 at its intermediate stopping position along a human eye's visual axisdenoted by S2<S1 involves a further clockwise rotation of the AIOL 33relative to the haptics system 32 to reach the channels 53B, displacingthe AIOL 33 in an anterior direction along the channels 53B to reach thegrooves 54B, and a clockwise rotation of the AIOL 33 relative to thehaptics system 32 (see FIG. 12). Positioning the AIOL 33 at its mostanterior position along a human eye's visual axis denoted by S3<S2involves a further clockwise rotation of the AIOL 33 relative to thehaptics system 32 to reach the channels 53C, displacing the AIOL 33 inan anterior direction along the channels 53C to reach the grooves 54C,and a further clockwise rotation of the AIOL 33 relative to the hapticssystem 32 (see FIG. 13).

Implantation of the AIOL assembly 31 in a human eye 10 after removal ofits natural crystalline lens 27 to leave its double layered capsulardiaphragm 29 including remnants of its anterior capsule 24 overlying itsstill intact posterior capsule 26 is now described with reference toFIGS. 14 and 15. The AIOL assembly 31 is set up such that the AIOL'slongitudinal axis 56 coincides with the haptics system's longitudinalaxis 39. The AIOL assembly 31 is typically implanted into a human eye 10after administration of topical drops of a cycloplegic drug for relaxingits iris muscles, thereby dilating its pupil for facilitating access toits posterior chamber 18 immediately behind its iris 14. Suchadministration also induces the human eye 10 into its relaxed ciliarybody state thereby tensioning its capsular diaphragm 29 which has someslack by virtue of the removal of its natural crystalline lens 27leaving its capsular diaphragm 29 for accommodation purposes. FIG. 14shows that the haptics system's puncturing members 44 are forciblyinserted into the sclera 12 at stationary anchor points AP for retainingthe AIOL assembly 31 in the annular ciliary sulcus 28. FIG. 14 alsoshows that the AIOL assembly 31 is deployed such that its longitudinalaxes 41 and 56 are co-directional and preferably co-axial with the humaneye's visual axis VA and the trailing surface 59A is urged in aposterior direction against the capsular diaphragm 29 tensioning same tobecome sufficiently taut to urge the AIOL 33 to its compressed state asshown in FIG. 9. The AIOL 33 is so deployed that constriction of theciliary body 19 is intended to enable the AIOL 33 to assume itsnon-compressed state as shown in FIG. 8 thereby affording accommodationover the full range of the reciprocal movement of the human eye'scapsular diaphragm 29. However, in the case of capsular contraction, theAIOL 33 is unable to assume its fully non-compressed state in the humaneye's constricted ciliary body state such that it remains at leastpartially compressed depending on the degree of the capsular contractionthereby diminishing its accommodation ability. The accommodation abilityof the AIOL 33 is restored by moving the AIOL 33 in an anteriordirection to either its intermediate stopping position or its mostanterior stopping position (see FIG. 15).

FIG. 16 show an AIOL assembly 90 including a discrete haptics system 32and a discrete dual bellows-like AIOL 91. The AIOL 91 has a longitudinalaxis 92 intended to be co-directional with a human eye's visual axis,and a housing 93 having a ring 94 with lugs 96 for traveling along thestepped tracks 52, an anterior member 97 with a leading surface 98, anda posterior member 99 with a trailing surface 101. The housing 93includes a leading shape memory resiliently elastically deformablebellows-like optical element 102 between the ring 94 and the anteriormember 97, and a trailing shape memory resiliently elasticallydeformable bellows-like optical element 103 between the ring 94 and theposterior member 99. The anterior member 97 is formed with blindmanipulation notches 104 for selectively receiving the handheldmanipulation tool's tip 38A for enabling in situ manipulation of theAIOL 33.

The ring 94, the anterior member 97, the posterior member 99, and theoptical elements 102 and 103 are preferably formed from suitable polymerbased biocompatible transparent material of different consistencies. Thering 94 is typically formed from a relatively rigid polymer material,for example, PMMA, whilst the anterior member 97 and the posteriormember 99 are formed from less rigid silicone or acrylic based polymermaterial, and the optical elements 102 and 103 are formed from stillsofter silicone gel or softer acrylic based polymer material. Forexample, the anterior member 97 and the posterior member 99 can beformed from aforesaid MED6400 polymer material and the optical elements102 and 103 can be formed from aforesaid MED3-6300 polymer material,Alternatively, the ring 94 can be formed with a membrane for dividingthe AIOL 91 into two compartments which can be injected with a suitablesilicone or water based gel. The anterior member 97 and the posteriormember 99 can be formed as flat optical members without any opticalpower or preferably as plano-convex optical members as shown.

FIG. 17 shows a unitary AIOL assembly 110 having a longitudinal axis 111intended for to co-directional with a human eye's visual axis, and ahaptics system 112 integrally formed with the AIOL 91 which therebyeffectively acts as the haptics system's main body. The haptics system112 includes a pair of diametrically opposite C-shaped elongated haptics113 extending from its AIOL 91 in opposite directions in a planeperpendicular to the longitudinal axis 111 in a similar manner to thehaptics system 32. In this case, the haptics 113 have regions 114impregnated with radiation sensitive bio-compatible materials such as IRsensitive indocyanine green (ICG), and the like, such that they arecapable of being plastically deformed on heating to a so-called glasstransmission temperature to enable post implantation in situ axialdisplacement as illustrated and described in aforesaid WO2005/104994.

FIG. 18 show the non-compressed shapes of the optical elements 102 and103 having a flat surface 104A in a non-compressed state of AIOL 91.FIG. 19 shows the optical element 103 bulging into the optical element102 to create a curved surface 104B on applying a compression force Fagainst the trailing surface 101 in the direction of the anterior member97 on retaining the ring 94 in a fixed position which in turn causes theoptical element 102 to expand in an anterior direction for distancingthe anterior member 97 away from the ring 94. The optical element 103bulges more into the optical element 102 with a greater compressionforce whereby the AIOL 91 has a continuously variable Diopter strengthfrom a minimum Diopter strength suitable for distance vision and amaximum Diopter strength suitable for near vision.

The optical element 102 preferably has a refractive index n2 which isgreater than the optical element's refractive index n1 whereby thecurved surface 104B acts as a concave lens with a negative optical powersuch that the AIOL 91 is suitable for near vision in its non-compressedstate (see FIGS. 18 and 20) and distance vision in its compressed state(see FIGS. 19 and 21). The AIOL 91 can be engineered to produce veryhigh negative refractive power in its compressed state so that asubject's eye will have a total negative power on application of acompression force F. In this case, a subject can wear spectacles withpositive lenses whereby the subject's eye and his spectacles constitutea Gallilean telescope enabling him to see far objects in a magnifiedfashion.

FIGS. 22-24 show a discrete AIOL 120 suitable for use in the hapticssystem 32 for self-anchoring implantation in a human eye's annularciliary sulcus. The AIOL 120 has a longitudinal axis 120A intended to beco-direction with a human eye's visual axis, a cylindrical housing 121having a leading end 121A fitted with an anterior member 122 and atrailing end 121B fitted with a piston 123 reciprocal with respect tothe housing 121. The housing 121 is formed from a suitable rigidbio-compatible transparent material, for example, PMMA, and the like.The anterior member 122 is formed with a pair of clamp members 124 forsnap fit insertion in a pair of apertures 126 formed in the housing 121.The piston 123 is formed with a pair of keys 127 for insertion in a pairof keyways 128 formed in a trailing surface 129 of the housing 121.Quarter turn rotation of the piston 123 in the housing 121 prevents thepiston 123 from being disengaged from the housing 121 but enablesreciprocation with respect thereto. The housing 121 is provided withperipheral apertures 131 relative to the longitudinal axis 120A and anannular flange 132 deployed between the trailing surface 129 and theapertures 131 (see FIGS. 23 and 24). Preferably both the anterior member122 and the piston 123 have positive optical power or alternatively onlyone of them has positive optical power as in the case of theplano-convex anterior member 122 and the flat piston 123.

The housing 121 houses a pair of shape memory disc-like optical elements133 and 134 in a similar fashion as the AIOL 91 insofar that the opticalelements 133 and 134 have a flat surface 136A in a compressed state ofthe AIOL 120 (see FIG. 23) and a curved surface 136B in its compressedstate (see FIG. 24). FIG. 24 shows the optical element 134 bulging intothe optical element 133 which in turn causes the optical element 133 tobulge radially through the apertures 131. In the case that the opticalelement 133 has a greater refractive index than the optical element 134,the curved surface 136B acts as a concave lens such that the AIOL 120 issuitable for near vision in its non-compressed state (see FIG. 23) anddistance vision in its compressed state (see FIG. 24). The leading end121A is formed with lugs 137 for traveling along the stepped tracks 52.The anterior member 122 is formed with blind manipulation notches 138(not shown) for selectively receiving the handheld manipulation tool'stip 38A for enabling in situ manipulation of the AIOL 120.

FIGS. 25-28 show a discrete AIOL 140 suitable for use in the hapticssystem 32 for self-anchoring implantation in a human eye's annularciliary sulcus. The AIOL 140 is similar in operation to be AIOL 120 butdiffers therefrom insofar as it is constructed as a single monolithicstructure for facilitating insertion into a subject's eye through arelatively small incision. The AIOL 140 includes a housing 141 having ananterior member 142, a piston member 143 joined to the housing 141 by aflexible membrane 144 enabling reciprocation between a non-compressedstate and a compressed state, peripheral apertures 146, and an annularflange 147. The housing 141 houses optical elements 148 and 149 whichcan be injected therein, and which have a flat surface 151A in thenon-compressed state of the AIOL 140 (see FIG. 27) and a curved surface151B in its compressed state (see FIG. 28). In the case that the opticalelement 148 has a greater refractive index than the optical element 149,the curved surface 151B acts as a concave lens such that the AIOL 140 issuitable for near vision in its non-compressed state (see FIG. 27) anddistance vision in its compressed state. (see FIG. 28). The housing 141is formed with lugs 152 for traveling along the stepped tracks 52. Theanterior member 142 is formed with blind manipulation notches 153 forselectively receiving the handheld manipulation tool's tip 38A forenabling in situ manipulation of the AIOL 140.

FIGS. 29 and 30 show a discrete AIOL 170 suitable for use in the hapticssystem 32 for self-anchoring implantation in a human eye's annularciliary sulcus. The AIOL 170 includes a cup-shaped housing 171 with ananterior member 172 and a trailing tubular piston 173 reciprocal betweena most extended position (see FIG. 29) and a most compressed position(see FIG. 30). The housing 171 houses a shape memory optical element 174resiliently elastically deformable between a non-compressed disc-likeshape (see FIG. 29), and a compressed shape bulging into the piston 173in a posterior direction on application of a compression force F (seeFIG. 30). The housing 171 is formed from a suitable rigid bio-compatiblematerial, for example, PMMA, and the like. The optical element 174 istypically constituted by a suitable silicone or water based gel having arefractive index greater than the refractive index of a human eye'saqueous humor such that the AIOL 170 is suitable for distance vision inits non-compressed state (see FIG. 29) and near vision in its compressedstate (see FIG. 30).

FIG. 31 shows a discrete AIOL 180 suitable for use in the haptics system32 for self-anchoring implantation in a human eye's annular ciliarysulcus. The AIOL 180 includes a cup-shaped housing 181 with an anteriormember 182 having a central aperture 183, a shape memory disc-likeoptical element 184, and a semi-spherical posterior member 186. Theoptical element 184 is resiliently elastically deformable between itsnatural disc-like shape and bulging through the aperture 183 onapplication of a compression force F. The housing 181 is formed from asuitable rigid bio-compatible material, for example, PMMA, and the like.The optical element 184 is typically constituted by a suitable siliconeor water based gel having a refractive index greater than the refractiveindex of a human eye's aqueous humor whereupon such that the AIOL 180 issuitable for distance vision in its natural state and near vision in itscompressed state.

FIG. 32 shows a discrete AIOL 190 suitable for use in a haptics systemadapted to be securely fixed in a human eye's annular ciliary sulcus.The AIOL 190 includes a cup-shaped housing 191 with an anterior member192 and a shape memory spherical optical element 193 resilientlyelastically deformable between a natural spherical shape and a flattenedshape on application of a compression force F thereagainst in thedirection of the anterior member 192. The optical element 193 istypically constituted by a suitable silicone or water based gel having arefractive index greater than the refractive index of a human eye'saqueous humor such that the AIOL 190 is suitable for near vision in itsnatural state and distance vision in its compressed state.

FIG. 33 shows a “push and twist” AIOL assembly 200 similar inconstruction and operation to the “push and twist” AIOL assembly 31 butdiffering therefrom insofar that a discrete AIOL 201 is inserted into adiscrete haptics system 202 from an anterior direction as opposed to aposterior direction. In this case, the AIOL 201 is provided with a pairof blind manipulation notches 203 for enabling in situ manipulation bymeans of a handheld manipulation tool 36.

FIG. 34 shows a “push and twist” AIOL assembly 210 similar inconstruction and operation to the “push and twist” AIOL assembly 31 butdiffering therefrom insofar that it has a reverse “push and twist”bayonet arrangement with respect to the “push and twist” bayonetarrangement 34. In other words, the AIOL assembly 210 includes a hapticssystem 211 and an AIOL 212, and the former is provided with lugs 213 andthe latter is formed with two or more equidistant stepped tracks 214.The reverse “push and twist” bayonet arrangement is advantageous overthe “push and twist” bayonet arrangement 34 insofar that a discrete AIOLcan be formed with an axial length L2 which is greater than a mainbody's axial length L1 for enabling in situ manual selective axialdisplacement along an adjustment stroke longer than the main body'saxial length L1. The AIOL 212 is formed with blind manipulation notches216 for enabling in situ manipulation by means of a handheldmanipulation tool 36. The reverse “push and twist” bayonet arrangementcan be implemented with an AIOL 212 inserted into a haptics system 211from either an anterior direction as shown or a posterior directionsimilar to the “push and twist” bayonet arrangement 34.

FIG. 35 shows an AIOL assembly 220 similar to the AIOL assembly 31 butemploying a screw thread arrangement 221 instead of the “push and twist”bayonet arrangement 34 for enabling relative movement of a discrete AIOL222 with respect to a discrete haptics system 223. The AIOL assembly 220can also be readily implemented to enable an adjustment stroke along ahuman eye's visual axis longer than a main body's axial length L1. TheAIOL 222 is provided with a pair of blind manipulation notches 224 forenabling in situ manipulation by means of a handheld manipulation tool36.

While the invention has been described with respect to a limited numberof embodiments, it will be appreciated that many variations,modifications, and other applications of the invention can be madewithin the scope of the appended claims. The discrete AIOLs 120, 140,170, and 180 can be readily formed as unitary AIOL assemblies similar tothe unitary AIOL assemblies 80 and 110.

The invention claimed is:
 1. An accommodating intraocular lens (AIOL)system for implantation in a human eye, comprising: an accommodatingintraocular lens comprising: a cup-shaped, cylindrical housing; ananterior member with a leading surface; a shape memory optical elementformed of gel and housed within the cup-shaped housing adjacent saidanterior member, the shape memory optical element resilientlyelastically deformable between a non-compressed state and a compressed,bulging state; and a piston reciprocally movable relative to the housingbetween an extended position and a compressed position depending onciliary muscle contraction, wherein application of a compression forceon the shape memory optical element by the piston compresses the shapememory optical element at a first location causing the shape memoryoptical element to bulge at a second location away from the firstlocation creating the compressed, bulging state suitable for nearvision; and a self-anchoring haptics system extending in a planeperpendicular to a visual axis of the accommodating intraocular lens andforming at least two spaced apart stationary anchor points for retainingthe accommodating intraocular lens in the eye.
 2. The AIOL systemaccording to claim 1, wherein the self-anchoring haptics system isintegrally formed with the accommodating intraocular lens.
 3. The AIOLsystem according to claim 1, wherein the housing has a diameter of atleast 6 mm to about 7 mm.
 4. The AIOL system according to claim 1,wherein the housing is formed of a silicone or acrylic based polymermaterial.
 5. The AIOL system according to claim 1, wherein theself-anchoring haptics system includes a pair of C-shaped hapticsextending from the accommodating intraocular lens in oppositedirections.
 6. The AIOL system according to claim 1, wherein theself-anchoring haptics system includes spaced apart pointed puncturingmembers.
 7. The AIOL system according to claim 1, wherein the shapememory optical element has a continuous slightly curvilinear leadingsurface in the non-compressed state.
 8. The AIOL system according toclaim 1, wherein the accommodating intraocular lens has a continuouslyvariable Diopter strength from a minimum Diopter strength suitable fordistance vision and a maximum Diopter strength suitable for near vision.9. The AIOL system according to claim 1, wherein the shape memoryoptical element has a refractive index greater than a refractive indexof aqueous humor of the eye such that the AIOL is suitable for distancevision in its non-compressed state and near vision in its compressedstate.